Event Information

Event Topic:
Medical Device E&L Testing – Things to know before you go

Event Description:
Key take-aways: The reality – extractables and leachables is a long hard road of testing. Sponsor partnership with the CRO is critical to successful outcomes. E&L testing may be painful now, but worth it long-term. Due to increased regulatory expectations, extractables and leachables testing can be a long and expensive endeavor, which can include unplanned additional rounds of testing. Detailed information provided by sponsors is necessary to meet regulatory requirements & pursue any potential testing optimization. A close partnership between the sponsor & test lab facilitates the best possible outcome, including a thorough toxicological risk assessment. Despite its challenges, E&L testing is not only useful in addressing systemic biological endpoints, it is also the key factor in reducing animal testing in general (it increases the potential for use of in vitro methods). It also provides long-term valuable material data inputs for potential future design verification steps, including supplier change notifications or manufacturing capacity expansions.

Date/Time:
Date(s) - 12/06/22
8:15 am - 10:30 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/88274227563:

Speaker Information

Event Speaker:
Robert S. Mueller

Event Speaker Title:
Toxicologist

Event Speaker Company:
Nelson Laboratories

Event Speaker Bio:

Robert Mueller has 8 years of experience working in the medical device industry. He has developed a unique perspective on testing from working for both a contract research organization and a medical device manufacturer. During his time with the medical device manufacturer, he planned and managed the execution of biological testing, chemical characterization, and wrote toxicological risk assessments for both MDR and 510(k) submissions. He is an ISO 10993-18 subject matter expert and as such he has designed custom studies for a broad range of medical devices to meet the biocompatibility requirements outlined in ISO 10993. He has provided all levels of regulatory support to a wide range of medical device companies. His expertise includes developing and qualifying analytical methods as well as conducting analytical data reviews. He has also authored regulatory body submissions and deficiency responses. Robert received his Bachelor of Science in Chemistry from the University of Utah and is currently pursuing a Master of Science in Pharmacology and Toxicology from Michigan State University. Robert is currently a toxicologist at Nelson Labs.

Event Details

Cost:
$0

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